A Phase I, Safety, Pharmacokinetic and Pharmacodynamic Study of rhEndostatin Protein Administered by Continuous Intravenous Infusion to Pediatric Patients With Cancer
- Patients will receive rhEndostatin intravenously continuously for 28 days and will be
enrolled into one of 2 dosing groups.
- During the initial course of treatment, subjects will be evaluated for
treatment-related side effects. If there are no side effects or disease progression,
they may receive an additional 28 days of continuous rhEndostatin.
- During the infusion of rhEndostatin, blood samples will be collected before, during and
after the drug is given to determine how much of the drug stays in the blood. Blood
will be drawn on days 1, 8, 22 and 29. After the completion of therapy, a blood sample
will be collected at least 3 days after to determine the level (if any) of rhEndostatin
still in the patients blood.
- Blood and/or urine samples to determine immune reactions against rhEndostatin as well
as molecules that tumors may use to stimulate new blood vessel growth will be drawn at
the start of the study as well as after the completion of each 28-day cycle and
completion of the study.
- When a tumor-specific marker that can be used to monitor the status of the disease is
present, blood samples for the measurement marker will be obtained at the start of the
study as well as after each cycle.
- Appropriate imaging studies (MRI, CT scan, x-ray) will be done after the completion of
the first two 28-day cycles and then at the completion of each 28-day cycle for the
duration of therapy.
- Treatment will be continued for 1 year and may be extended if the drugs are well
tolerated and disease progression has not occured.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety of rhEndostatin protein in pediatric patients with recurrent or progressive cancer that is measurable and that is refractory to standard therapies.
Mark W Kieran, MD,PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|